NCT02975817

Brief Summary

The investigators wish to undertake a randomized controlled non-inferiority trial to evaluate the ability of a simple and low-cost method (Hibler´s method of wrapping the patient in multiple insulating layers) to prevent intraoperative heat-loss in children undergoing neurosurgery under anesthesia in Malawi. The control group will be heated actively with the use of warm-air blankets. The aim of this study is to evaluate whether Hibler´s method can provide a cheap and technically simple way of adequately preserving the patients´ core temperature in the operating theatre in a resource-poor setting.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
76

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2016

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

November 24, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 29, 2016

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 12, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 12, 2019

Completed
Last Updated

March 1, 2021

Status Verified

February 1, 2021

Enrollment Period

2.7 years

First QC Date

November 24, 2016

Last Update Submit

February 24, 2021

Conditions

Hypothermia

Keywords

pediatric, intraoperative, neurosurgery, inadvertent

Outcome Measures

Primary Outcomes (1)

  • incidence of hypothermia

    incidence of core temperatures below 36,0 C

    from start of surgery till end of surgery

Secondary Outcomes (4)

  • incidence of postoperative shivering

    postoperative period, from start of stay at HDU (High Dependency Unit) till 5 hours into this stay

  • Oxygen requirements

    postoperative period, from start of stay at HDU (High Dependency Unit) till 5 hours into this stay

  • Degree of alertness

    postoperative period, from start of stay at HDU (High Dependency Unit) till 5 hours into this stay

  • Proportion of surgery time spent normothermic

    from start of surgery till end of surgery

Study Arms (2)

Hibler's

EXPERIMENTAL

Insert description from protocol

Other: Hibler's

Warm Air

ACTIVE COMPARATOR

Insert description from protocol

Other: Warm Air

Interventions

Hibler'sOTHER

Passive body heat retention using multiple-layer tight wrapping of patient

Hibler's
Warm AirOTHER

Active, convective warming of patient using warm air blanket

Warm Air

Eligibility Criteria

AgeUp to 11 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • I. Age under 12 years. II. Ensured bed in HDU for postoperative management. III. Undergoing general anaesthesia with endotracheal intubation for planned cranial procedures; e.g. craniotomies, ventriculo-peritoneal shunt placements, endoscopic third ventriculostomies and similar procedures with a predominantly cranial access.
  • IV. Informed parental/guardian consent given

You may not qualify if:

  • I. Pts. aged 12 years or older. II. Pts. with a temperature upon arrival at the anaesthetic suite lower than 36,0 °C III. Pts. with a temperature upon arrival at the anaesthetic suite greater than 37,5°C IV. Pts. judged to be unsuited for the standardized anaesthetic technique chosen (due to known allergy, known or suspected difficult airway requiring other anaesthetic interventions, cardiovascular conditions incompatible with the standard anaesthetic agents or due to any other condition where the chosen technique is deemed unsafe)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Queen Elizabeth Central Hospital

Blantyre, Malawi

Location

Related Publications (1)

  • Feyling AC, Kamalo PD, Hanche-Olsen T, Chikumbanje SS, Zsidek AS, Ponzi E, Raeder J. Preventing hypothermia in pediatric neurosurgery in Africa-A randomized controlled non-inferiority trial of insulation versus active warming. Acta Anaesthesiol Scand. 2024 Feb;68(2):167-177. doi: 10.1111/aas.14341. Epub 2023 Oct 26.

    PMID: 37882145DERIVED

MeSH Terms

Conditions

Hypothermia

Condition Hierarchy (Ancestors)

Body Temperature ChangesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Anders C Feyling, MD

    Oslo University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

November 24, 2016

First Posted

November 29, 2016

Study Start

June 1, 2016

Primary Completion

February 12, 2019

Study Completion

February 12, 2019

Last Updated

March 1, 2021

Record last verified: 2021-02

Locations

MA(1)